| 摘要 |
The invention relates to a stable liquid oily ready-to-use formulation, comprising: (i) an active pharmaceutical ingredient, which has hydrophobic and/or lipophilic properties and/or which exhibits stability problems in aqueous environments, (ii) an oily vehicle, in which the active pharmaceutical ingredient is dissolved or dispersed, and which is selected from vegetable oils, synthetic oils, fatty acids or combinations thereof; and optionally one or more of a thickening/suspending agent, an antioxidant, a preservative, a flocculating agent, a surface stabilising agent, a sweetener, a flavouring agent, an emulsifier and a colouring agent, or combinations thereof, as well as to said formulation for use in the medical treatment of a patient group selected from (i) paediatric patients, (ii) elderly patients, (iii) patients suffering from dysphagia, or (iv) patients requiring medication via nasogastric or gastrostomy tubes and to a method for preparing a stable liquid oily ready-to-use formulation comprising the following steps: (a) heating the oily vehicle under mild stirring, (b) dissolving the antioxidant, (c) dissolving or melting the thickening/suspending agent and optionally emulsifying agent(s), until a clear solution is obtained, and cooling the solution to room temperature, (d) optionally adding further thickening/suspending agent, (e) adding and optionally disperging the active pharmaceutical ingredient, (f) optionally adding the sweetener, flavouring and/or colouring agents, (g) completing the volume with the oily vehicle to the desired amount, and (h) optionally performing homogenisation. |
